FDA draft guidance and clinical trials

In 2015, the Food and Drug Administration released the Clinical Trial Imaging Endpoint Process Standards draft guidance for the clinical trial industry. According to the FDA, the purpose of the guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products. More specifically, […]

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How much does a data query cost?

We all hear about the negative impact data queries have in clinical trials.  Their abundance, which has been described and written about widely, results in a lot of hand wringing and declarations of hope that we can do away with most of them. The questions I am most interested in understanding are: What causes data […]

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